| CTRI Number |
CTRI/2020/10/028647 [Registered on: 26/10/2020] Trial Registered Prospectively |
| Last Modified On: |
26/10/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Efficacy of warm foot bath in promotion of early sleep onset among hospitalized children |
|
Scientific Title of Study
|
Efficacy of warm foot bath in promotion of early sleep onset among hospitalized children |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Bedre Suwarna Shriram |
| Designation |
Principal |
| Affiliation |
nursing college civil hospital beed |
| Address |
lodha complex near giri hospital adarsh nagar dist: beed 431122
nursing college civil hospital beed dist: beed
431122
Bid
MAHARASHTRA
431122
India |
| Phone |
9623480764 |
| Fax |
02442221560 |
| Email |
suwarnakulthe@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Archana Mourya |
| Designation |
Professor |
| Affiliation |
Datta Meghe Institute Of Medical Sciences(deemed to be university) |
| Address |
Shrimati Radhikabai Meghe Memorial College Of Nursing Sawangi Wardha.
Shrimati Radhikabai Meghe Memorial College Of Nursing Sawangi Wardha.
Nagpur
MAHARASHTRA
442001
India |
| Phone |
8788276500 |
| Fax |
02442221560 |
| Email |
archanatej95@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Bedre Suwarna Shriram |
| Designation |
Principal |
| Affiliation |
Nursing College Civil Hospital Beed |
| Address |
lodha complex near giri hospital adarsh nagar dist: beed 431122
lodha complex near giri hospital adarsh nagar dist: beed 431122
Bid
MAHARASHTRA
431122
India |
| Phone |
8329197176 |
| Fax |
02442221560 |
| Email |
suwarnakulthe@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Bedre Suwarna Shriram |
| Address |
Lodha complex Adarsh Nagar Beed District: BEED 431122 |
| Type of Sponsor |
Other [self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| bedre suwarna |
Acharya vinoba bhave rural hospital sawangi |
department of paediatrics vinoba bhave rural hoepital sawangi wardha
Wardha
MAHARASHTRA |
9623480764
02442221560
suwarnakulthe@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Doctoral Research Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
, (1) ICD-10 Condition: Z779||Other contact with and (suspected)exposures hazardous to health, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
contemporary protocol |
the children who fulfills inclusion & exclusion criteria will be assessed for early onset of sleep without giving intervention |
| Intervention |
warm foot bath |
Every child admitted who fulfills inclusion & exclusion criteria will be included in study. firstly demographic data will be collected and child will be assess before and after the intervention for onset of sleep with the help of structured observational checklist and experimental group will be administered with warm foot bath. |
| Intervention |
warm foot bath |
warm foot bath to the hospitalized children |
|
|
Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
1) Children admitted in hospital.
2) Willing to participate in study.
3) Who understands the instructions. |
|
| ExclusionCriteria |
| Details |
1) Children suffering with convulsive disorders.
2) Unconscious children
3) Mentally handicapped.
4) Having paralyzed extremities.
5) children on intravenous infusion frequently |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| sleeping pattern of the child |
sleeping pattern of the child |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nursing intervention will be included in pediatric care |
At hospitalization as well as home care |
|
|
Target Sample Size
|
Total Sample Size="500"
Sample Size from India="500"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 1 |
|
Date of First Enrollment (India)
|
01/12/2020 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This study is interventional evaluatory approach, randomized controlled trail time series design study. As the child admitted in hospital following inclusion and exclusion criteria will be assessed for early sleep onset and interventional group will be administered for warm foot bath for 3 days respectively and after every intervention child will be assessed for sleep onset with the help of structured obsevational checklist . and the control group will be assessed for early sleep onset with same checklist without giving any intervention. |